US FDA Nods Merck's Therapy To Treat Patients with Cervical Cancer

The US Food and Drug Administration (FDA) has approved Merck's anti-PD-1 therapy, Keytruda, in conjunction with chemotherapy radiation therapy (CRT) for the treatment of patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer. Merck is referred to as MSD outside of the US and Canada.

The approval is based on data from the phase 3 KEYNOTE-A18 trial, in which Keytruda plus CRT demonstrated an improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 41% (HR=0.59 [95% CI, 0.43-0.82]) compared to placebo plus CRT in patients with FIGO 2014 Stage III-IVA disease. Median PFS was not reached in either group. This approval marks the third indication for Keytruda in cervical cancer and the 39th indication for Keytruda in the US, as per pharmabiz.

“Today’s approval of Keytruda plus chemoradiotherapy is welcome news and gives patients with newly diagnosed FIGO 2014 Stage III-IVA cervical cancer, for the first time ever, the option of an anti-PD-1-based regimen to treat their cancer,” said Dr. Bradley Monk, oncologist and professor of obstetrics and gynaecology at University of Arizona’s College of Medicine and Creighton University School of Medicine. “This Keytruda-based regimen offers a new treatment option for these patients, so today’s approval has important implications for the way we treat them moving forward.”

Immune-mediated adverse reactions, which can be severe or lethal, can occur in any organ or tissue and affect several physiological systems at the same time. Keytruda medication can cause immune-mediated adverse responses such as pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and problems of allogeneic hematopoietic stem cell transplantation. The important immune-mediated adverse reactions listed here may not contain all potentially severe and fatal immune-mediated adverse events.